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CTRI Number  CTRI/2024/06/068327 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This is a clinical study to evaluate the potential benefits of anti-aging supplement on improvement in quality of life , biological age and other healthy outcome . 
Scientific Title of Study   A Prospective, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Multiple- Arm, Parallel Study to evaluate the safety, tolerability, and pharmacokinetics of RNM24 in healthy adult participants 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EP_RNM_001_24 version 01dated 28mar2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Specialist Hospital 
Address  Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar,
opd 1 2 floor research department Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar,
Bangalore
KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Specialist Hospital 
Address  Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
opd 1 2 floor,research department Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
Bangalore
KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Specialist Hospital 
Address  Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
opd room 1 research department 2 floor Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
Bangalore
KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Source of Monetary or Material Support  
Dr Chikkalingaiah Siddegowda opd room 1 research department 2 floor Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092. 
 
Primary Sponsor  
Name  Dr Chikkalingaiah Siddegowda 
Address  Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chikkalingaiah Siddegowda  Medstar Specialist Hospital  Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
Bangalore
KARNATAKA 		 09884457106

drchikkalingaiahmedstar@gmail.com 
Dr V SAKTHIVEL  Vinayaka Mission Medical College and Hospital  KEESHAKASAKUDIMEDU, KOTUCHERRY P O KARAIKAL
Karaikal
PONDICHERRY 		 9842426095

drshruthisakthi@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Medstar Specialty Hospital Ethics Committee  Approved 
VinayakaMissionMedicalcollege  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anti-Ageing supplement 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo Capsule ,once daily for 90 days 
Intervention  RNM24  Nicotinamide food supplement, once daily for 90 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult healthy male/females aged 40 to 65 years.
2. Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m2.
3. Participants who are willing to provide written Informed Consent for participating in the study
4. Participants who are able to follow verbal and written study directions.
5. Participants must be able to maintain consistent diet and lifestyle habits throughout the study.
6. Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.
7. Participants willing to administer assigned dietary supplements for 3 months. 
 
ExclusionCriteria 
Details  1. Participants on current use of prescription or over-the-counter nicotinic acid.
2. Participants using any statin drugs.
3. Participants having used any tobacco product or used a recreational drug in the past 6 months.
4. Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator.
5. Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease.
6. Participants with history of drug or alcohol abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To assess NAD+ Values in blood
2) Assessment of Biological Age
3) Physical Performance is assessed by endurance test measured on six minutes walking test
4) Change in BMI
5) Quality of Life Assessment will be done using SF-36 Questionnaire 		 Baseline to end of study. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Routine clinical laboratory tests: Haematology, Biochemistry, Lipid Profile, LFT, RFT parameters
2) Safety will be assessed based on number of adverse events
3) Tolerability will be assessed based on number of subjects drop out due to drug related adverse events 		 Baseline to end of study. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is to assess the safety and tolerability of IP as a dietary supplement for human consumption. The current study aims to comprehensively evaluate its potential effects on pharmacokinetics, physical performance, biological age and overall quality of life. These findings will expand our understanding of IP’s therapeutic potential and guide its future clinical applications in anti-aging interventions. 
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